Combination Chemotherapy in Treating Patients With Advanced Cancer of the Pancreas

NCT00002955 | Completed Phase 2 DMC

• 3 other identifiers: CDR0000065428 (3P-95-1)LAC-USC-3P951NCI-G97-1173
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with advanced cancer of the pancreas.

Conditions

Pancreatic Cancer

Keywords

stage IV pancreatic cancer

Interventions

fluorouracil DRUG

leucovorin calcium DRUG

trimetrexate glucuronate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically proven advanced pancreatic cancer with metastatic disease Bidimensionally measurable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT, SGPT and alkaline phosphatase less than 3 times upper limit of normal Serum albumin at least 3.0 g/dL Renal: Serum creatinine no greater than 1.5 mg/dL Other: Not eligible for higher priority protocol No prior malignancy within 5 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective birth control No underlying medical condition precluding treatment PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior or concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy No prior radiotherapy to only site(s) of measurable disease Fully recovered from therapy Surgery: Fully recovered from prior surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033-0800, United States

Location

Related Publications (1)

• Garcia AA, Leichman L, Baranda J, et al.: Phase II study of trimetrexate (neutrexin), 5-fluorouracil and leucovorin (NFL) in advacne pancreatic. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A971, 253a, 1999.

  RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Fluorouracil; Leucovorin; trimetrexate glucuronate

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Agustin Garcia, MD

  University of Southern California

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 12, 2004
• Study Start: August 1, 1995
• Primary Completion: May 1, 2000
• Study Completion: June 1, 2006
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

US (1)